空气和蒸汽混合式的灭菌方案-洁定hanslarsson.ppt

Air-Steam Mixture Sterilization Solution Delicate BFS containers and pre-filled syringes 空气－蒸汽混合灭菌解决方案 应用于吹灌封和预灌装注射器产品的终端灭菌,PDI Jinan September 2012 PDI ， 2012年9月于济南 Presentation by Hans Larsson/Kevin Qian – Getinge 主讲人：洁定公司 乐瀚森/钱鼎,Difficulties with terminal sterilization of your delicate containers 柔性容器终端灭菌相对困难,Important features on sterilization process灭菌过程的重要特征 Fast process 过程迅速 High degree of Sterility Assurance 高度的无菌保证值 No deformation on products 产品不变形,2,Sep 2012,Hans Larsson - Getinge - PDI Jinan 2012,Difficulties with terminal sterilization of your delicate containers 柔性容器终端灭菌相对困难,How to choose? 如何选择 Process it quickly and to a high degree of Sterility Assurance, but then it will not be in good shape. 灭菌迅速并获得高的无菌保证值，但产品形状受到影响 Process it quickly and ensure it remains in good shape, but it may not be fully sterile.灭菌迅速并保持产品形状，但不能完全灭菌 Process it to a high degree of Sterility Assurance and remain in good shape, but it will take a long time. 获得高的无菌保证值并保持产品形状，但需要很长的灭菌时间 At first glance … … you can only pick any two 在快速处理、无菌保证和产品形状三者之间只能选择两项…,3,Sep 2012,Hans Larsson - Getinge - PDI Jinan 2012,Steam Sterilization 蒸汽灭菌柜,Traditional Steam Sterilizer 传统的蒸汽灭菌柜Used for sterilization of many different products within Healthcare, Biomedical Research and Pharmaceutical Production 广泛应用于医疗、生物医学和制药行业Used for a variety of products such as: 可用于不同的产品，比如： Hard goods (e.g. instruments, components, glassware parts) 硬物（比如器械、部件、玻璃器皿） Porous / Wrapped Goods (e.g. textiles, Tyvek® bags) 多孔/包裹物品 （比如织物、Tyvek袋子） Liquids, Parenterals 液体、注射剂Both for sterilization of products as well as decontamination of Bio-Hazardous waste. 可对产品灭菌，也可以对有生物危害的废物灭菌,4,Sep 2012,Hans Larsson - Getinge - PDI Jinan 2012,Why risk of deformation? 为何产品包装会产生变形,What happens during heating of product in a Steam Sterilizer? 在蒸汽灭菌过程中的加热阶段发生了什么？ Steam is used to heat the product from the outside – pressure in the chamber rises 蒸汽在容器外部对产品进行加热，灭菌器腔体压力不断上升 Pressure in a sealed container rises as it is heated due to expansion of air and other factors 被加热的密闭容器由于气体膨胀及其他因素引起容器内部的压力上升 Total internal pressure will be sum of water vapor pressure and air pressure 内部压力为水蒸汽压力和空气压力之和,5,Sep 2012,Hans Larsson - Getinge - PDI Jinan 2012,Why risk of deformation?为何产品包装会产生变形,What happens during cooling of product in a Steam Sterilizer? 在蒸汽灭菌过程中的冷却阶段发生了什么？ Energy is only lost from container by transmission to environment – need to remove steam from chamber 密闭容器能量的损失只能通过向腔体内传递的方式 － 所以需要去除腔体内的蒸汽 Replace the steam with air so that the containers do not explode 采用空气代替蒸汽，以防止密闭容器爆裂 Radiation from external surfaces – Slow cooling process 容器外表面热辐射 － 非常缓慢的冷却过程 Pressure in the sealed container is still very high 密闭容器内的压力仍然很高 The container can be sterilized in a steam sterilizer only if the container can withstand a pressure difference只有能承受内外压差的密闭容器才能在普通蒸汽灭菌器内进行灭菌,6,Sep 2012,Hans Larsson - Getinge - PDI Jinan 2012,Why risk of deformation?为何产品包装会产生变形,Which Products can withstand a pressure difference? 哪些产品可以承受压差？ LVP:s and parenteral in delicate containers cannot withstand a pressure difference 柔性容器不能承受压差 Some SVP:s like glass ampoules and crimp-capped vials can withstand a pressure difference. 一些玻璃安瓿和轧盖西林瓶能承受压差 If you have the time to wait… 如果您有时间去等待的话……,7,Sep 2012,Hans Larsson - Getinge - PDI Jinan 2012,Difficulties with terminal sterilization of your delicate containers柔性容器终端灭菌相对困难,How to have it fast, sterile and in good shape? 如何实现快速灭菌、包材形状完好？,8,Sep 2012,Hans Larsson - Getinge - PDI Jinan 2012,Fast,Sterile,No deformation,Processes available 可实现的灭菌方式,9,Sep 2012,Hans Larsson - Getinge - PDI Jinan 2012,Water Cascade 水浴式 Why water? Water very good carrier of energy. Especially good during cooling phase. 为何采用水浴？水是良好的能量载体， 特别在冷却过程中。

Water is filled in the chamber and circulated during process. 水进入灭菌腔，并在整个过程中循环 Circulating water is heated with e.g. steam to heat up product 循环水被蒸汽加热，进而加热产品 Possibility to add air support pressure可以加压力补偿 Circulating water is cooled with e.g. cold water to cool down product 循环水被冷却，进而冷却产品 Extremely fast process, but products are wet afterwards 灭菌过程非常快，但灭菌完成后产品是湿的Processes available可实现的灭菌方式,10,Sep 2012,Hans Larsson - Getinge - PDI Jinan 2012,Steam and air mixture 蒸汽和空气混合式 Steam and Air mixed in process在灭菌过程中蒸汽和空气混合 Steam is used to heat up product蒸汽用于加热产品 Dry pre-heating is optional 预热可作为选项 Possibility to add air support pressure - Fan makes the surrounding homogenous 可以加压力补偿 － 顶部风机使灭菌腔内环境更均一 Air cooled by internal heat exchanger is used to cool down product. Air is circulated with fan 内部热交换器冷却腔内空气，进而冷却产品。

空气在风机的作用下在腔内循环 Process time can be very fast, depending on cooling system, and products are dry afterwards 灭菌过程可以非常快速，产品在灭菌后为干燥状态,Temperature Gradient and F0 温度梯度和F0值,11,Sep 2012,Hans Larsson - Getinge - PDI Jinan 2012,Steam and air mixture 蒸汽和空气混合Example on steam and air mixture sterilizer: 蒸汽和空气混合灭菌器示例During heatup, product at the bottom heats more quickly than product at the top 加热阶段，在灭菌底部的产品比顶部的产品升温快Conversely, during cooling, the load at the bottom cools more quickly 相反，在冷却阶段，底部比顶部的冷却快 The net result is that the total heating effect (F0 value) is the same 所以整个过程的F0值是相同的 This is a well accepted and understood principle, and customers validate their sterilizers accordingly 这是广泛接受并能理解的原则，在灭菌器验证中完全实现 If steam/air flow is horizontal, the same applies but with a temperature gradient horizontally 如果蒸汽/空气的流向为水平，以上结论同样适用，但温度梯度是水平的。